Kornimate/medical-research-clean huggingface dataset:
anti-fibrinolytic and anti-inflammatory effects of local infiltration of tranexamic acid in patients with calcaneal fractures

Conditions: Tranexamic Acid; Fibrinolysis; Inflammatory; Fracture

Summary: background. consensus is lacking regarding the use of tranexamic acid (txa) in calcaneal fracture surgery. this study aims to investigate the hypothesis that local infiltration of txa in the post-operation would maintain hemoglobin (hb) level, reduce incision drainage volume and risk of infection in patients with displaced intra-articular calcaneal fractures. methods. a total of 120 patients with displaced intra-articular calcaneal fractures who received extensible lateral l-shaped approach were included in this trial and equally randomized to receive one single dose of 1g txa or 1g normal saline after closing incision. the demographic data and fracture characteristics, intra-operative indicators, laboratory tests and visual analogue scale (vas) scores, incision drainage volume, and incision-related complications were collected and compared between the two groups.


Eligibility criteria:
inclusion criteria: * adult patients with age of eighteen years or older; * diagnosis of closed and unilateral displaced intra-articular calcaneal fracture; * agreement to receive one of the two treatment strategies; * agreement to participate in regular follow-up after surgery exclusion criteria: * open calcaneal fractures; * polytrauma of the ipsilateral lower limb; * systemic inflammatory or infectious diseases; * previous history of calcaneal fracture or bone tumor; * allergies to drugs used, or refused to accept the specified treatment strategy.
management of dyspnea: use of hand held fan

Conditions: Lung Cancer

Summary: this research is planned as a randomized controlled experimental study to determine the effect of air stimulation to the face with a hand fan in the management of dyspnea in lung cancer patients. the universe of the research was carried out between december 2022 and february 2024, izmir provincial health directorate, university of health sciences, suat seren chest diseases and surgery training and research hospital will consist of cancer patients. individuals who meet the sampling selection criteria from the specified universe will constitute the sample of the research. the sample number of the research was determined as a result of the power analysis made with the g\*power program. as a result of the power analysis, based on the t-test in independent groups, the minimum number of samples to be taken was 27 people for a group with 1:1 ratio, 0.80 power, effect value 0.80 and 0.05 significance level. randomization of the sample will be ensured by accepting the first patient who applied to the outpatient chemotherapy unit randomly and with an appointment at the beginning of the study to the experimental group, and the next patient to the control group. considering the losses, it is planned to work with 60 people, 30 people in the intervention group and 30 people in the control group. individual descriptive information form, medical research council scale (mmrc), cancer dyspnea scale, vital signs follow-up form, eastern cooperative oncology group (ecog) performance scale and general comfort scale short form will be used.


Eligibility criteria:
inclusion criteria: * 18 years and older * diagnosed with lung cancer * mmrc dyspnea scale score ≥2 * ecog performance score score ≥3 * volunteered to participate in the research exclusion criteria: * having a fever of 38⁰c and above in the last 24 hours * inability to communicate cognitively and verbally * having a psychiatric illness

Keywords: lung cancer dyspnea fan therapy comfort oncology nursing
awake pronation for covid-19 treatment

Conditions: Covid-19 Infection

Summary: observational studies have shown that prone position (pp) in spontaneously breathing patients, may improve oxygenation in individuals with acute respiratory failure (arf), due to covid-19 infection. none so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion

observational studies have shown that prone position (pp) in spontaneously breathing patients, may improve oxygenation in individuals with acute respiratory failure (arf), due to covid-19 infection. these studies were mainly physiological and reported in a subset of patients a poor tolerance. indeed most of the beneficial effects on gas exchage disappeared in around 40% of tyhe patients, once the patients regained the supine position. none so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion. this holds particularly true in those patients affected by mild de-novo arf (pao2/fio2 ratio within the range of 200-300), where any form of respiratory support like continuous positive airways pressure (cpap), high flow nasal cannula (hfnc) or noninvasive ventilation (niv), may be not yet indicated, especially if the patients are admitted to a regular ward as for the case of covid-19 pandemics, due to the lack of "protected" beds.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 infection using pcr * acute respiratory failure ( 200 \<pao2/fio2 \<300) and respiratory rate \< 30 atti/min * o2 therapy initiated \<72 hrs * informed consent exclusion criteria: * glasgow coma scale (gcs) \< 13 * ph\ 45 mmhg * need for hfnc, cpap, niv or intubation * hemodynamic instability increase of 80-90 mmhg or reduction of 30-40 mmhg in systolic blood pressure * severe arrythmia of myocardial infarction * need for sedation * intolerance to pp * pregnancy * body mass index (bmi) \> 35 kg/m2.
seizures in infants hospitalized in pediatric intensive care unit for bronchiolitis

Conditions: Bronchiolitis; Seizures; Hyponatremia

Summary: bronchiolitis is the leading cause of pediatric intensive care unit admission in infants. seizures during bronchiolitis may be a neurological complication of respiratory viruses but also of the treatments. the investigating team's hypothesis is that the incidence of seizures is not so so uncommon in infants hospitalized in the pediatric intensive care unit for severe bronchiolitis.


Eligibility criteria:
inclusion criteria: * age \< 90 days * hospitalization from january 1st, 2010 to april 30th, 2018 in the pediatric intensive care unit (picu) of pediatric hospital in lyon * with bronchiolitis (clinical diagnosis according to american academy of pediatrics) exclusion criteria: * neurological history that may explain the occurrence of seizures * significant congenital heart disease

Keywords: infant
erythropoietin alfa in elderly subjects with unexplained anemia

Conditions: Anemia

Summary: the primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (hb) levels in elderly outpatients with unexplained anemia. the secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to assess the safety of epoetin alfa in the study population.

eligible subjects will be recruited out of the companion study "anemia in the elderly" (nct00640172), after active participation in that study is complete. subjects will have had a full hematologic evaluation, and unexplained anemia will have been previously defined. subjects will provide baseline physical function testing, including exercise testing on a treadmill and testing how far patients can walk in 6 minutes (walk test), as well as quality of life; activity level; and mental functioning. study visits will be weekly, and the dose level may be adjusted to achieve the target hemoglobin level within 16 weeks. once at target, the drug will be taken for a total of 12 additional weeks. the maximum time on the study drug could be 28 weeks, and the minimum time be on the 14 weeks. the walk tests and questionnaires will be repeated when the target hemoglobin level is reached, and when treatment is completed. the tests about quality of life, activity level, and mental functioning will be repeated at the end of treatment. follow-up visits will be every 4 weeks for 12 weeks to check for side effects.

Eligibility criteria:
inclusion criteria: * aged ≥ 65 * hb ≤ 11 g/dl * outpatient at either the va palo alto health care systems (vapahcs) or stanford hospital and clinics (shc) * independently living in the community (ie, not institutionalized or living in a group home) * ability to understand and the willingness to sign a written informed consent document * performance level ecog 2 or better * diagnosis of unexplained anemia exclusion criteria: * substance abuse or mental health or other problems that would affect compliance with the protocol * predicted mortality based on co-morbidities of less than 3 months * on any erythropoiesis-stimulating agent in the prior 3 months * known hiv; hepatitis b; or hepatitis c chronic infection * clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study * serum albumin \< 3 g/dl * use of an investigational medication or participation in an investigational study within 4 weeks prior to enrollment in the trial * liver disease as defined as total bilirubin ≥ 2 g/dl or ast/alt ≥ 2 times the upper limit of normal * allergy to recombinant human erythropoietin * estimated glomerular filtration rate by modification of diet in renal disease (mdrd) equation of \< 30 ml/min/1.73 m2 or dialysis * history of proximal deep venous thrombosis or pulmonary embolism within the past 12 months * known contraindication to exercise testing
adenovirus (rgdcradcox2f)

Conditions: Adenocarcinoma of Pancreas

Summary: this is a single center, phase i dose finding study of a single direct tumor injection of an rgd modified conditionally replicative adenovirus (rgdcradcox2f) in persons with adenocarcinoma of the pancreas. the study is designed to determine the mtd of rgdcradcox2f that corresponds to the maximum desired toxicity of ≤ 20%.


Eligibility criteria:
inclusion criteria: * histologically documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes after staging by ct or mri and endoscopic ultrasound. * one prior line of therapy is permitted (i.e. neo-adjuvant therapy); however, at least 4 weeks must have elapsed between the last dose of drug and the injection of rgdcradcox2f. * must be able to tolerate esophagogastroduodenoscopy (egd) and the tumor must be accessible by endoscopic ultra sound. participants will be excluded if obtaining biopsies are deemed unsafe or not feasible. * age 18 years of age or older at the time of consent * normal cardiac and pulmonary function based on history and physical exam * participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) for at least 1 month after day 1. exclusion criteria: * pregnant or breastfeeding. persons of child-bearing potential must have a negative pregnancy test (serum or urine) with 14 days of study enrollment. * other pancreatic malignancies (e.g., neuroendocrine tumors and mucinous cystic) and adenocarcinomas of the ampulla, bile ducts, and duodenum. * tumors in mucosal regions or close to an airway, major blood vessel, or spinal cord that in the opinion of the enrolling investigator could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. * known history of human immunodeficiency virus (hiv) infection * known history of or active acute or chronic active hepatitis b or c infection * serious concurrent infection or medical illness, which in the enrolling investigator's opinion would jeopardize the ability of the participant to receive the treatment outlined in this protocol with reasonable safety. * requires immunosuppression ≥10mg/day of prednisone for more than 1 week. * history of or active known or suspected autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents. * disease beyond the regional lymph nodes * active diffuse pancreatitis * active inflammatory conditions * prior gastrojejunostomy
conversion from mpa to zortress (everolimus) for gi toxicity post-renal transplantation

Conditions: Kidney Transplant Rejection; Gastrointestinal Disorder, Functional

Summary: patients who receive renal transplantation at barnes jewish hospital (bjh) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (mpa), and prednisone. however, due to the effects of mpa on the gastrointestinal tract, patients often complain of gi adverse effects. current practice is to either dose-reduce mpa or convert the patient to an alternative agent, typically azathioprine. both of these strategies have limitations, largely due to concerns related to efficacy. everolimus (evr) has demonstrated similar efficacy to mpa in renal transplantation and may offer a benefit related to gi adverse effects, so the investigators will convert patients to evr in this study. patients who are within their first year post-transplant will be converted to evr upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of gi adverse effects will be conducted over 1 year post-enrollment.


Eligibility criteria:
inclusion criteria: 1. kidney transplant recipients at washington university/barnes-jewish hospital 2. experiencing gi toxicity from mpa as determined by the treating physician within 12 months post-renal transplant 3. on standard immunosuppression with tacrolimus and prednisone exclusion criteria: 1. dual organ or kidney after another solid organ transplant 2. presence of a preexisting significant gi condition that does not have a presumed causal relationship with mpa 3. evidence of any gi disorder induced by an infection, underlying medical condition, or concomitant medication other than mpa 4. estimated glomerular filtration rate (egfr) \<40 ml/min at time of possible conversion 5. proteinuria \>1 gram/day at time of possible conversion 6. profound bone marrow suppression at the time of possible conversion as defined as: * hemoglobin \<10 g/dl * white blood cell (wbc) \< 3 k/cumm * platelets \<100 k/cumm 7. wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma) 8. elevated total cholesterol (\>350 mg/dl) and/or triglycerides (\>500 ng/dl) at time of possible conversion 9. hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives
less surgical radicality for early stage cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: this study is an open-label, multicenter, randomized, phase ii non-inferiority trial (proof of concept study). its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage ia2-ib1 cervical cancer ≤ 2cm.

the purpose of this study is to evaluate the safety and efficacy of extrafascial hysterectomy compared with modified radical hysterectomy, both plus level 1 pelvic lymph-node dissection, in patients with early stage ia2-ib1 cervical cancer ≤ 2cm. the experimental procedure will be considered to be promising for treatment of stage ia2-ib1 cervical cancer ≤ 2cm if the bayesian posterior probability of "the difference of the 3-y dfs rate is less than the non-inferiority margin of 5%" is at least 50%. thus, using this proof of concept design, the planned sample size is 40, with 20 cases per arm, which provides 72% chance of satisfying the above criteria, under the hypothesis that the lowest 3-y dfs rate in each arm is 90%. as required, adjuvant therapy will include cisplatin-based chemo-radiation or pelvic radiation alone (ebrt +/- intracavitary brachytherapy) indicated according to the #gog92 and #gog109 criteria.

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix by leep, cone or cervical biopsy; 2. aged between 18 and 70 years; 3. performance status 0-2 (ecog, eastern cooperative oncology group) and / or greater than 70 points by the karnofsky scale; 4. figo early stage ia2-ib1 ≤ 2cm; 5. appropriated cardio-respiratory, hepato-renal and hematological reserves; and 6. signing of the consent form. exclusion criteria: 1. limiting systemic comorbidities including neuro-psychiatric disorders or obesity; 2. apparent or confirmed uncontrolled infections; 3. other malignancies in activity; 4. previous radiation or chemotherapy treatment or major pelvic surgery; 5. history of drug allergies, and pregnancy or breast feeding; and 6. evidence of more extensive disease at the time of surgery.
improving non-invasive ventilation

Conditions: Acute Respiratory Failure

Summary: a single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.


Eligibility criteria:
inclusion criteria: * treatment with non-invasive ventilation * informed consent exclusion criteria: * refusal of informed consent

Keywords: niv acute respiratory failure hypoxia hypercapnia non-invasive ventilation hospital ward
effects of bariatric surgery on pelvic floor fonctions in obese women

Conditions: Urinary Incontinence; Obesity

Summary: urinary incontinence is well documented as a comorbidity of obesity. studies demonstrate improvement of incontinency after weight loss. however, the mechanisms are still not clear. aim of our study to analyze the effects of bariatric surgery on pelvic floor function in women.

obesity is considered an important public health problem, both in developed and developing countries. obese people are at a higher risk for developing various comorbidities: type ii diabetes, dyslipidemia, cardiovascular and cerebrovascular diseases, coagulation disorders, degenerative joint disease, some types of cancer, sleep apnea and urinary incontinence women suffering from obesity are more likely to develop urinary incontinence, especially when related to stress. excess weight is a modifiable risk factor. it is believed that weight reduction may be an effective treatment for urinary incontinence. the aim of this study is to analyze the effects of weight loss induced by bariatric surgery on pelvic floor function. taking into account that modest weight loss (5% to 10%) already brings benefits to women with obesity and incontinence, one may assume even more marked improvement owing to the massive loss of weight by surgical means.

Eligibility criteria:
inclusion criteria: * body mass index ≥ 40 kg/m2 * \>18 years old * participants who provided written informed consent exclusion criteria: * history of gynecologic operation time under one year * history of pelvic physiotherapy * chronic obstructif lung disease * norologic disease * women in menopause

Keywords: obesity bariatric surgery urinary incontinence pelvic floor
first-in-human trial of home brain pressure measured using kitea icp sensor, placed during hydrocephalus shunt surgery.

Conditions: Hydrocephalus

Summary: patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. patients and their caregivers live with the constant fear that the tube will block. warning symptoms include irritability, headaches and vomiting. unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation. the investigators want to improve the lives of patients with hydrocephalus. they have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. the device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). this study is a first-in-human safety study to show it is safe for patient use.

participants with hydrocephalus who are at risk of repeated bouts of hospitalisation associated with shunt failures and therefore likely to benefit from being able to monitor intracranial pressure will be recruited. 10 adult (\>16 years) and 10 children (1-15 years) participants will be recruited in a staggered fashion to allow appropriate evaluation of outcomes. participants will be recruited when they present to hospital requiring a shunt placement (or revision). at the same time as this surgery, the kitea sensor will be placed in the brain near the shunt. participants will be asked to make measurements of their brain pressure at home using the kitea icp system for the next 3 months. aside from the placement of the kitea sensor and home measurements of icp using the kitea icp system, all clinical interventions will be standard of care.

Eligibility criteria:
inclusion criteria: * participants with a condition requiring cerebral spinal fluid shunting who are undergoing initial shunt placement or shunt revision surgery. * adults: age \> 16 years; children: age \>1 and \<15 exclusion criteria: * adults: unable to give informed consent * paediatric: failure to obtain assent in a cognitively competent child along with parental consent or parent unable to consent. * cortical mantle \< 20 mm * neurologic or other condition that would prevent compliance with protocol * terminal illness with expected survival \< 1 year * unable to participate in follow-up for 3 months (e.g., travelling overseas for an extended period) * underlying medical condition that would make the participant more prone to surgical infections * other active implanted medical devices e.g. pacemaker, cochlear implant, implantable cardioverter defibrillator, deep brain stimulation devices * participants with conditions likely to require radiation therapy

Keywords: intracranial pressure
a study of herceptin (trastuzumab) in combination with whole brain radiotherapy in patients with her-2 positive breast cancer

Conditions: Breast Cancer

Summary: this single-arm, multicenter, open-label study will evaluate the efficacy and safety of herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with her-2 positive breast cancer. the patients will receive herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. the anticipated time on study treatment is 18 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * diagnosis of breast carcinoma with her-2 overexpression * at least one measurable brain metastasis * patients for whom, according to investigator assessment, whole brain radiotherapy is the best therapeutic option * performance status (who) \</=2 * life expectancy \>/=3 months exclusion criteria: * presence of neoplastic meningitis * any prior radiotherapy to the brain * patients for whom, according to investigator assessment, stereotactic radiotherapy is the best therapeutic option * previous neoplasms, other than breast carcinoma, within 5 years since enrolment